The Effect of Orally Administered Iron-saturated Lactoferrin on Systemic Iron Homeostasis in Pregnant Women Suffering From Iron Deficiency and Iron Deficiency Anaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hemoglobin (Hb) level.
研究概览
简要总结
This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous sulphate in the context of iron deficiency anemia with pregnancy.
Half of participants will receive lactoferrin, while the other half will receive ferrous sulphate.
详细描述
Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.
Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.
Lactoferrin is a new generation oral iron that has long been recognized as a member of the transferrin family of proteins and an important regulator of the levels of free iron in the body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that lactoferrin may represent a promising new strategy for oral iron replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with single fetus
- •Hb count < 11g/dL
- •ferritin level < 12 ng/dL
- •Gestational age (14 - 30 weeks)
排除标准
- •Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).
- •Associated bleeding disorder
- •Anaemia requiring blood tranfusion (Hb < 7g/dL)
- •Hypersensitivity to iron preparations
- •Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)
研究组 & 干预措施
Lactoferrin
100mg of bovine lactoferrin (Pravotin sachets, Hygint, Egypt) twice a day.
干预措施: Lactoferrin (Drug)
ferrous sulphate + folic acid (vitamin B9)
150mg of dried ferrous sulphate + folic acid (vitamin B9) 0.50mg (Ferrofol, E.I.P.I.C.O, Egypt) three capsules per day.
干预措施: ferrous sulphate + folic acid (vitamin B9) (Drug)
结局指标
主要结局
Hemoglobin (Hb) level.
时间窗: 4 weeks
to be measured before and after treatment.
次要结局
- serum ferritin level.(4 weeks)
研究者
Khaled Mohamed Balsha
principal investigator
Ain Shams Maternity Hospital